(137 days)
Upper Arm Electronic Blood Pressure Monitor, Models FC-BP100,FC-BP102,FC-BP110,FC-BP111,FC-BP112 are intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual by using a non-invasive technique in which an inflatable cuff is wrapped around the upper arm. The devices' features include irregular pulse rhythm detection during measurement, and will display a alert signal with the reading when irregular heartbeat is detected. The devices' feature includes Bluetooth function to transmit data to an external Bluetooth device with wireless communication.
The subject device, Upper Arm Electronic Blood Pressure Monitor, is an automatic non-invasive blood pressure monitor which can be driven by 4 AA batteries or type-C USB (optional). It uses an inflatable cuff which is wrapped around the patient's upper arm to measure the systolic and diastolic blood pressure as well as the pulse rate of adult at household, not for neonate or pregnancy. The unit uses the oscillometric method of blood pressure measurement. It means the unit detects the movement of your blood through your brachial artery, and converts your blood pressure into a digital reading. The unit is simple to use because a stethoscope is not needed while using an oscillometric monitor. The unit stores the blood pressure and pulse rate in the memory after completing a measurement each time. 2x90 sets of measurement values can be stored automatically. The earliest record will be deleted automatically to save the latest measurement value when more than 2x90 sets. The unit also calculates an average reading based on the values of the latest 3 times measurement. This blood pressure monitor has the function of blood pressure classification, which is convenient for you to judge whether your blood pressure is normal or not. This blood pressure monitor has voice broadcast function. During measurement and recall the memory, there will be voice operation tips. The device detects an Irregular HeartBeat (IRB) (a Heartbeat that is more than 25% slower or 25% faster from the average Heartbeat) two or more times during the measurement, the irregular heartbeat Symbol will appear on the display with the measurement values. The device features a built-in "Bluetooth Data Transmission" function, which enables the device automatically transmit measuring results to paired Bluetooth-enabled device (FC-BP100 and FC-BP110 applied). There is a maximum pressure safety setting at 300 mmHq, when the pressure is more than 300mmHg, the device will exhaust fast automatically. No operation for 1 minute the device will shut down automatically. The device includes model FC-BP100.FC-BP101.FC-BP102.FC-BP110. FC-BP111. FC-BP112,they are same except the appearance.
The provided text describes the clinical validation study for the Upper Arm Electronic Blood Pressure Monitor (Models FC-BP100, FC-BP101, FC-BP102, FC-BP110, FC-BP111, FC-BP112).
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria (from ISO 81060-2:2018) | Reported Device Performance |
|---|---|---|
| Blood Pressure Accuracy | Within ±5 mmHg (as per ISO 81060-2:2018) | Meets ±5 mmHg requirement |
| Pulse Rate Accuracy | Not explicitly stated in the document | Not explicitly stated in the document |
Note: The document explicitly mentions "The results shown that the accuracy of proposed device meet the requirements of ISO 81060-2:2018 within the ±5mmHg." This refers to blood pressure accuracy. While the Table 2 Performance Comparison lists "Pulse Accuracy: ±5% of reading value" as a specification for both the subject and predicate devices, it does not explicitly state that this was an acceptance criterion for the clinical validation or that the clinical study results confirmed this specific numerical accuracy for pulse rate. However, compliance with ISO 81060-2:2018 generally covers both BP and pulse rate accuracy indirectly through its clinical validation methodology for automated sphygmomanometers.
2. Sample Size and Data Provenance
- Sample Size (Test Set): 138 subjects
- Data Provenance: Not explicitly stated (e.g., country of origin). The study was a prospective clinical trial, as "relevant volunteers were collected to conduct actual clinical trial of blood pressure measurement."
3. Number of Experts and Qualifications
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). It mentions:
- "Auscultation applied as gold standard"
- "qualified calibrated mercurial sphygmomanometer used as control group"
This implies that trained clinical personnel (likely physicians or nurses experienced in blood pressure measurement via auscultation) were involved in generating the ground truth.
4. Adjudication Method
The document does not specify an adjudication method like 2+1 or 3+1. The use of "Auscultation applied as gold standard" with a "qualified calibrated mercurial sphygmomanometer" suggests that the auscultation readings themselves were considered the definitive ground truth, potentially implying readings taken by at least two observers per subject to ensure accuracy, though this is not explicitly detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned. The study focused on the standalone performance of the device against a gold standard, not on how human readers' performance improved with or without AI assistance.
6. Standalone Performance
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The clinical trial directly evaluated the device's accuracy in measuring blood pressure against the auscultation gold standard.
7. Type of Ground Truth Used
- Expert Consensus / Reference Method: The ground truth was established by auscultation using a "qualified calibrated mercurial sphygmomanometer." This is considered a clinical reference method, often performed by trained experts.
8. Sample Size for the Training Set
- The document does not mention a separate training set or its sample size. The description of the clinical trial refers to the validation of the device's performance after its development.
9. How Ground Truth for the Training Set Was Established
- Not applicable, as a separate training set and its ground truth establishment method are not described in the provided text. The clinical trial described is for validation of the device's performance.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).